FDA Registration
Active
🇺🇸 United States
DOT AMERICA, INC.
Reg #: 3011461101
·
FEI: 3011461101
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
1
Classifications
9
Registration Details
- Registration Name
- DOT AMERICA, INC.
- Registration Number
- 3011461101
- FEI Number
- 3011461101
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 335 Towerview Dr
- City
- Columbia City
- State
- IN
- ZIP
- 46725
- Country
- US
Owner / Operator
- Firm Name
- DOT America, Inc.
- Operator Number
- 10048730
- Address
- 335 Towerview Drive
- City
- Columbia City
- State
- IN
- Postal Code
- 46725
- Country
- US
- Correspondent
- Michael Venturini
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2022-04-11 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2015-10-21 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-12-27 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2023-08-11 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2022-04-11 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2022-04-11 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2022-04-11 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2022-04-11 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2025-08-14 |
Proprietary Names
Simplify® Cervical Artificial Disc
DJO Surgical
MBH - PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER JWH -
Porous Coated Discovery Elbow
Apex Knee System, Model KC-230XY, KC- 240XY [No Holes, 2 Holes]
EVOLUTION NitrX Medial-Pivot Knee - prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/pol
Small Diameter Implant (SDI)
3 Dental Implant
HSD - PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED PHX - shoulder prosthesis, reverse configuration
Identity Revision Stems
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)